Bakery Square MSPO labs
Pittsburgh, Pennsylvania, 15206, United States
Completed
NCT Number: NCT02234505
Physiologic Range of Step-by-step Variations in Lower Limb Prosthesis Forces During Walking
In human gait there is a certain amount of variation between steps; some considered physiological and owed to variations in environment or posture, and some severe enough to be indicative of gait instabilities that may lead to stumbling and falling. In users of lower limb prosthetics, such gait instabilities are of especially great interest.
The study investigates the correlation between socket alignment quality and gait step-by-step variability in users of trans-tibial-prosthetics. It is hypothesized that a clearly defined range of step-by-step variability exists, and that therefore step-by-step variability is suitable as an outcome variable for the assessment of socket alignment.
A sample of ten persons with trans-tibial amputation will be recruited for this pilot study. Subjects will be asked to walk on different natural surfaces while the socket alignment is successively perturbed. Step-by-step variations in horizontal ground reaction forces and torsional moments will be measured and statistically compared.
Completed
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- activity classification of K2 to K4
- experience in prosthesis use of at least one year
- stated ability to walk pain free for at least 30 minutes
Exclusion criteria
- age of less than 18 years
- acute or ongoing residual limb pain
- use of a prosthesis that is not suitable for installation of the load cell (e.g. is too short, or has non-removable cosmesis)
Treatment and study plan
Prosthetic alignment perturbation
ProcedureProsthetic ankle plantar-flexion will be modified in different degrees, devices (prosthetic components) will not be modified from baseline condition
Primary outcomes
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Step-by-step variability
Time frame: 2 hours
Peak horizontal ground reaction force (Fx and Fy) as well as peak axial torsion moment (Mz) will be extracted for 10 consecutive intermediary steps for each testing condition. Total range in Newtons over the 10 step sample, as well as maximal difference between consecutive steps in Newtons and percent will be reported for statistical analysis.
Sponsors and collaborators
Lead sponsor
University of Pittsburgh
Other
Collaborators
- American Orthotic and Prosthetic Association
Registry information
Official study title
Physiologic Range of Step-by-step Variations in Lower Limb Prosthesis Forces
Important dates
- Study start
- 2014
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Sep 9, 2014
- Registry last updated
- Dec 4, 2015
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.